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This implies which the doable microbial contamination of the method and/or product or service should be prevented right before it transpires. Consequently, the standard methods of output and/or production units should really be certain aseptic procedure, proper sterilization procedures, sterility assurance, top quality Manage and assurance; and als
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) wherever the Energetic ingredient comprises A significant portion of the pill and the place control of excess weight can be presumed to generally be an enough control of drug content material uniformity. Excess weight variation will not be an enough indication of content material uniformity in which the drug substance comprises a comparatively sm